Job Description

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

The Manager/Sr. Manager, Analytical Services provides technical and operational leadership for an assigned analytical team. This role leads method development, qualification, and routine testing activities within its area of focus, ensures team delivery against project timelines and quality standards, and holds full project ownership for assigned programs. The Manager/Sr. Manager mentors team members, drives GMP compliance, and maintains cross-functional alignment to support broader department goals.

Responsibilities

Qualifications

• Platform leadership: Advanced-to-expert working knowledge of the assigned analytical area (HPLC/UPLC, CE/CE-SDS/cIEF, GC, or compendial/physicochemical testing) with sufficient cross-platform understanding to assess technical risk, resource work, and challenge scientific conclusions.
• HPLC/UPLC: Able to oversee development and lifecycle performance of chromatographic methods, including column/mobile-phase/gradient selection, system suitability, integration strategy, troubleshooting, robustness, qualification/validation, transfer, and GMP readiness.
• GMP testing: Accountable for team readiness and compliant execution of release, in-process, characterization, and other GMP testing; ensures trained analysts, qualified instruments, approved methods/specifications, contemporaneous documentation, peer review, deviation management, and on-time delivery.
• Stability testing: Oversees GMP and non-GMP stability testing, including schedule/capacity planning, timepoint execution within protocol windows, sample and method readiness, data review, trend awareness, OOS/OOT escalation, and coordination with Stability, QA, QC, and project teams.
• Method lifecycle and investigations: Leads qualification/validation strategy, transfer readiness, method changes, OOS/OOT/Laboratory Investigations, root-cause assessment, CAPA, and continuous improvement using sound scientific and regulatory judgment.
• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field; Master's or PhD preferred.
• 10-12 years of relevant analytical experience, with a focus aligned to the assigned team (chromatography/HPLC, CE/GC, or compendial/raw material testing).
• Demonstrated experience in a GMP environment.
• Prior supervisory, team lead, or senior scientist mentoring experience.

FLSA: Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.